Evaluating protocol lifecycle time intervals in HIV/AIDS clinical trials.

BACKGROUND: Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. PURPOSE: In this study, we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as to identify potential correlates of prolonged development and implementation. METHODS: We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by National Institutes of Health's HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/IV). We also examined several potential correlates to prolonged development and implementation intervals. RESULTS: Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2½ years) and implementation times (>3 years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. LIMITATIONS: The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects present for a specific study phase may have been masked by combining protocols into phase groupings. Presence of informative censoring, such as withdrawal of some protocols from development if they began showing signs of lost interest among investigators, complicates interpretation of Kaplan-Meier estimates. Because this study constitutes a retrospective examination over an extended period of time, it does not allow for the precise identification of relative factors impacting timing. CONCLUSION: Delays not only increase the time and cost to complete clinical trials but they also diminish their usefulness by failing to answer research questions in time. We believe that research analyzing the time spent traversing defined intervals across the clinical trial protocol development and implementation continuum can stimulate business process analyses and re-engineering efforts that could lead to reductions in the time from clinical trial concept to results, thereby accelerating progress in clinical research.

The Benefits of Intergenerational Wisdom-Sharing: A Randomized Controlled Study.

Adolescents' opportunities to benefit from the life wisdom of older persons are very limited. To address this issue, we designed and tested the Building a Community Legacy Together (BCLT) program based on research on the benefits of older people's wisdom for youth development. In the intervention, the youth participants were trained prior to conducting interviews with older persons regarding their advice for living. The youth participants analyzed the information obtained and presented a summary report to the community. The participants were 93 middle and high school youth who were randomly assigned to the treatment condition with the BCLT program (n = 47) or to the control condition (n = 46). The outcome measures included sense of purpose, self-esteem, attitudes toward older people, confidence interacting with older people, and interest in working with older people. Quantitative and qualitative data were also collected regarding the subjective assessments of the program's success. We found significant positive effects for the BCLT participants regarding their sense of purpose in life, attitudes toward older people, comfort interacting with older people, and interest in working with older people. The subjective assessments of the participants were overwhelmingly positive. The findings indicate that BCLT had positive effects for the youth participants and support the further development and testing of wisdom-sharing intergenerational programs.

Identifying and Understanding the Non-Clinical Impacts of Delayed or Cancelled Surgery in Order to Inform Prioritisation Processes: A Scoping Review.

The COVID-19 pandemic has resulted in significant delays to non-urgent elective surgery. Decision making regarding prioritisation for surgery is currently informed primarily by clinical urgency. The ways in which decision making should also consider potential social and economic harm arising from surgical delay are currently unclear. This scoping review aimed to identify evidence related to (i) the nature and prevalence of social and economic harm experienced by patients associated with delayed surgery, and (ii) any patient assessment tools that could measure the extent of, or predict, such social and economic harm. A rapid scoping review was undertaken following JBI methodological guidance. The following databases were searched in October 2020: AMED; BNI; CINAHL; EMBASE; EMCARE; HMIC; Medline; PsychINFO, Cochrane, and the JBI. A total of 21 publications were included. The findings were categorised into five themes: (i) employment, (ii) social function and leisure, (iii) finances, (iv) patients' experiences of waiting, and (v) assessment tools that could inform decision making. The findings suggest that, for some patients, waiting for surgery can include significant social, economic, and emotional hardship. Few validated assessment tools exist. There is an urgent need for more research on patients' experiences of surgical delay in order to inform a more holistic process of prioritising people on surgical waiting lists in the COVID-19 pandemic recovery stages.

Engaging Older Adults in Environmental Volunteerism: The Retirees in Service to the Environment Program.

Purpose of the Study: Retirees in Service to the Environment (RISE) is a program designed to promote participation of older people in volunteering for the environment. Based on principles of adult learning and best practices for the development of effective volunteer programs, RISE engaged older individuals in environmental volunteering and involved them in community stewardship activities. Design and Methods: This article details the development and formative evaluation of RISE. We describe program assessment, benefits to the community, and effects on participants. Results: The program successfully recruited individuals new to environmental volunteering and substantial hours of volunteer time were provided to communities. Program satisfaction was high and preliminary evidence suggests positive outcomes from RISE participation. Implications: The innovative structure combined with local relevance of the RISE program has the potential to expand older adults' engagement in environmental volunteerism.

Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks.

RATIONALE, AIMS, AND OBJECTIVES: Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. METHODS: A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. RESULTS: Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms. CONCLUSIONS: The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings.

Modeling the dissemination and uptake of clinical trials results.

A select set of highly cited publications from the National Institutes of Health (NIH) HIV/AIDS Clinical Trials Networks was used to illustrate the integration of time interval and citation data, modeling the progression, dissemination, and uptake of primary research findings. Following a process marker approach, the pace of initial utilization of this research was measured as the time from trial conceptualization, development and implementation, through results dissemination and uptake. Compared to earlier studies of clinical research, findings suggest that select HIV/AIDS trial results are disseminated and utilized relatively rapidly. Time-based modeling of publication results as they meet specific citation milestones enabled the observation of points at which study results were present in the literature summarizing the evidence in the field. Evaluating the pace of clinical research, results dissemination, and knowledge uptake in synthesized literature can help establish realistic expectations for the time course of clinical trials research and their relative impact toward influencing clinical practice.